On 15 June 2018 Health Canada announced the publication of proposed Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals) and the Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals). The regulations specify that for the purposes of Section 21.8 of the Food and Drugs Act, as amended by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), hospitals are the prescribed healthcare institutions that must provide information in their control to the minister of health.
Pursuant to the proposed amendments, all hospitals must provide the specified information relating to serious adverse drug reactions and medical device incidents (as defined in the proposed amendments) directly to Health Canada within 30 days of first documenting the reaction or incident in the hospital. The reporting requirements apply to:
- pharmaceuticals (prescription and non-prescription);
- biologic drugs (excluding vaccines that are part of a routine immunisation programme);
- radiopharmaceuticals;
- disinfectants; and
- medical devices.
However, the requirements exclude these products when used in clinical trials or as part of the Special Access Programme. The consultation period will end on 30 August 2018.
For further information on this topic please contact Urszula Wojtyra at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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